(55 days)
The Mediaid SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.
Mediaid SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in adhesive film, rigid spring-loaded clip, or foam and Velcro wrap. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.
The provided document describes the Mediaid SpO2 Sensor and its clearance. However, it does not include detailed acceptance criteria or a comprehensive study report with all the requested information. The document focuses on demonstrating substantial equivalence to predicate devices based on a clinical hypoxia study and other tests.
Here's the information that can be extracted and a summary of what is not present:
Missing Information:
- Specific numerical acceptance criteria for SpO2 accuracy (e.g., A_rms value, range of acceptable deviation).
- Specific numerical acceptance criteria for pulse rate accuracy.
- The exact "reported device performance" against those criteria.
- Sample size used for the test set beyond "2 or subjects" which is likely a typo for "20 subjects".
- Data provenance details like country of origin for the clinical hypoxia study.
- Number of experts, their qualifications, or adjudication methods for ground truth, especially for the clinical hypoxia study.
- Whether an MRMC comparative effectiveness study was done, or its effect size.
- Sample size for the training set or how its ground truth was established, as this is a standalone device without an explicit AI/ML component described for training.
Available Information from the Document:
-
Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in a table format with numerical criteria and corresponding reported performance. The document generally states that the device was "found to be equivalent to predicate sensors" and "2 or [likely "20"] subjects" were tested.
-
Sample sized used for the test set and the data provenance:
- Sample Size (Test Set): "2 or subjects" (likely a typo, intended to be "20 subjects")
- Data Provenance: Clinical hypoxia studies conducted in an "independent research lab." The country of origin is not specified, but the submission is to the US FDA. The study was retrospective or prospective is not stated, but clinical hypoxia studies are typically prospective.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not specified. The ground truth was established by an "arterial blood co-oximeter." Experts might have been involved in the operation or interpretation, but their role in establishing "ground truth" (beyond operating the co-oximeter) is not detailed.
-
Adjudication method for the test set: This information is not specified.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: An MRMC comparative effectiveness study was not done, and there is no mention of AI assistance in this context, as the device is an SpO2 sensor, not an AI diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device's performance was evaluated in a standalone manner as an SpO2 sensor. The "clinical hypoxia studies" compared the sensor's readings to arterial blood co-oximetry. It's an algorithm-only performance in the sense that the sensor produces a reading directly.
-
The type of ground truth used:
- For oxygen saturation (SpO2): Arterial blood co-oximeter
- For pulse rate: Samples were analyzed on a "facorater J ou vi [likely a typo for a type of device or method] performed to verify pulse rate accuracy." Further details on this are not provided.
-
The sample size for the training set: This is a physical sensor, not an AI/ML model that typically requires a "training set" in the computational sense. Therefore, this concept does not apply directly to the information provided. The development process would involve calibration and internal testing, but not a "training set" as understood in a machine learning context.
-
How the ground truth for the training set was established: See point 8. Not applicable in the context of this device and information provided.
Summary of Device Performance Study (as described):
The Mediaid SpO2 Sensors were evaluated through "clinical hypoxia studies" conducted in an "independent research lab."
- Methodology: The SpO2 sensors were compared directly to an "arterial blood co-oximeter," which served as the ground truth.
- Outcome: The sensors were "found to be equivalent to predicate sensors" based on this comparison.
- Pulse Rate: "Samples analyzed on a facorater J ou vi performed to verify pulse rate accuracy."
- Other Tests: Biocompatibility, electrical safety, and EMC testing were also performed to demonstrate conformance with established industry standards.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).